Cleared Traditional

K062065 - RIVA LUTING PLUS

K062065 is the FDA 510(k) clearance for RIVA LUTING PLUS by Southern Dental Industries, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K062065 · Southern Dental Industries, Inc. · Dental device
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Nov 2006
Decision
118d
Days
Class 2
Risk

K062065 is an FDA 510(k) clearance for the RIVA LUTING PLUS. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Southern Dental Industries, Inc. (Bensenville, US). The FDA issued a Cleared decision on November 15, 2006 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Southern Dental Industries, Inc. devices

Submission Details

510(k) Number K062065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2006
Decision Date November 15, 2006
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

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